A Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Primary Aldosteronism

Participants diagnosed with primary aldosteronism were randomly assigned to the low-dose group, high-dose group or placebo group for a double-blind treatment period. Participants subsequently entered an open-label period to assess long-term efficacy and safety.

Inclusion criteria

• Aged ≥18 years , regardless of gender.
• Diagnosed with primary aldosteronism (PA).
• Mean seated office systolic blood pressure (msSBP) ≥145 mmHg.
• Receiving stable background antihypertensive therapy.
• Serum potassium tested at local laboratory ≥3.0 mmol/L and <5.0 mmol/L.
• Morning serum cortisol >3 μg/dL.
• Voluntarily participate in the trial and provide written informed consent. Agree to comply with trial contraception and reproductive restrictions.

Exclusion criteria

• Mean seated office systolic blood pressure (msSBP) ≥180 mmHg and/or mean seated office diastolic blood pressure (msDBP) ≥110 mmHg.
• History or diagnosis of malignant hypertension, hypertensive emergency, hypertensive crisis or hypertensive encephalopathy.
• History or diagnostic evidence of other secondary hypertension.
• Prior surgical resection for adrenal adenoma.
• Medication compliance <80% or >120%.
• PA complicated with acute coronary syndrome, myocardial infarction, percutaneous coronary intervention or stroke.
• Receiving treatment with potassium-binding agents.
• Any clinically significant abnormal laboratory findings that, in the Investigator's opinion, may interfere with the evaluation of efficacy and/or safety endpoints of the study.
• Subjects with severe hepatobiliary diseases.
• Positive test for human immunodeficiency virus antibody (HIV), hepatitis C antibody (HCV), treponema pallidum antibody (TP), or positive hepatitis B surface antigen (HBsAg).
• Type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
• Morbid obesity.
• Receiving blood transfusion for anemia.
• History of adrenal insufficiency.
• History of solid organ or bone marrow transplantation.
• Prior exposure to rituximab or cytotoxic chemotherapeutic agents.
• Recent use of strong CYP3A inhibitors or CYP3A inducers.
• Concomitant use of antihypertensive drugs, or other chemical drugs, biological products, traditional Chinese medicines or natural products deemed inappropriate by the Investigator.
• Active malignancy or past medical history of malignant tumor.
• Patients on hemodialysis or strict salt-restricted diet.
• Gastrointestinal disorders or prior gastrointestinal surgery that may affect drug absorption or excretion.
• Known or suspected hypersensitivity to aldosterone synthase inhibitors; known contraindication or hypersensitivity to any background concomitant medications.
• History of substance abuse or chronic alcohol abuse.
• Female subjects who are pregnant, breastfeeding, or with positive pregnancy test result.
• Recent blood donation or major blood loss (>400 mL), or clinically diagnosed hypovolemia.
• Participation in any interventional clinical trial with investigational product within 3 months prior to screening (or within 5 half-lives of the investigational product, whichever is longer); or enrollment in any medical device clinical trial with implanted/used study device.
• Night shift work within 3 days prior to study visit and within 3 days before ambulatory blood pressure monitoring.
• Presence of clinically significant, unstable or uncontrolled concomitant diseases as assessed by the Investigator at screening.
• Any other conditions judged by the Investigator to render the subject unsuitable for trial participation and likely to confound efficacy and/or safety assessment.